Overweight Clinical Trial
Official title:
Whey Protein Micelles and Thermogenesis In Overweight Subjects
The main objective of the trial is to measure the thermogenic effect of two different doses
of whey protein microgels.
It will be a randomized crossover double-blind design conducted in 20 subjects.
Primary objective and outcome:
The primary objective of the trial is to measure the thermogenic effect of two different
doses of whey protein microgels (WPM).
Secondary objectives and outcomes:
Explore the mechanism of action of WPM on thermogenesis including:
Protein turnover in response to the dose and the source of protein (WPM versus casein)
Insulinemic and glycemic response to the dose and source of protein (WPM versus casein)
Design: The proposed study is a randomized double-blind, placebo-controlled, single center,
crossover design.
At the start of the study, subjects will be randomly assigned to 4 different groups in a
crossover design, where they will be asked to consume a beverage containing Product 1: 0g of
protein (maltodextrin control) Product 2: 30g of WPM Product 3: 50g of WPM Product 4: 50g of
micellar casein (MC) Number of subjects: The number of subjects will be 15. Sufficient
subjects should be recruited to provide a 30% drop-out rate. Therefore 20 subjects will be
needed including drop-outs.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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